Trial Outcomes & Findings for A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer (NCT NCT01087970)
NCT ID: NCT01087970
Last Updated: 2014-05-19
Results Overview
PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)
Results posted on
2014-05-19
Participant Flow
Participant milestones
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
Received ≥1 Dose of Any Study Drug
|
69
|
|
Overall Study
Completed 6 Cycles
|
69
|
|
Overall Study
Efficacy Population
|
58
|
|
Overall Study
Received Carboplatin
|
63
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=69 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
|
European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Index Score (n=47)
|
0.721 units on a scale
STANDARD_DEVIATION 0.248 • n=5 Participants
|
|
European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Visual Analog Scale (VAS) Score (n=47)
|
66.106 units on a scale
STANDARD_DEVIATION 20.658 • n=5 Participants
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HNC)
NOD (n=57)
|
56.32 units on a scale
STANDARD_DEVIATION 37.87 • n=5 Participants
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HNC)
UOS (n=57)
|
78.51 units on a scale
STANDARD_DEVIATION 32.20 • n=5 Participants
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HNC)
EIP (n=57)
|
71.93 units on a scale
STANDARD_DEVIATION 34.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)Population: All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.
PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=58 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Progression-Free Survival (PFS)
|
5.1 months
Interval 3.9 to 6.0
|
SECONDARY outcome
Timeframe: From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)Population: All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.
OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=58 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
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|---|---|
|
Overall Survival (OS)
|
11.1 months
Interval 7.6 to 14.8
|
SECONDARY outcome
Timeframe: From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)Population: All treated participants excluding those from a noncompliant study site.
PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=58 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
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|---|---|
|
Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)
|
25.9 percentage of participants
Interval 15.3 to 39.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)Population: All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=43 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
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|---|---|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in Index Score at Cycle 2 (n=43)
|
0.038 units on a scale
Standard Deviation 0.233
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in Index Score at Cycle 4 (n=29)
|
0.070 units on a scale
Standard Deviation 0.147
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in Index Score at Cycle 6 (n=24)
|
-0.063 units on a scale
Standard Deviation 0.249
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in Index Score at monotherapy Cycle2 (n=14)
|
0.016 units on a scale
Standard Deviation 0.098
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in Index Score at monotherapy Cycle 4 (n=7)
|
0.059 units on a scale
Standard Deviation 0.080
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in VAS Score at Cycle 2 (n=41)
|
3.854 units on a scale
Standard Deviation 21.600
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in VAS Score at Cycle 4 (n=28)
|
2.107 units on a scale
Standard Deviation 24.894
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in VAS Score at Cycle 6 (n=21)
|
0.333 units on a scale
Standard Deviation 16.716
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in VAS Score at monotherapy Cycle 2 (n=14)
|
-1.500 units on a scale
Standard Deviation 16.919
|
|
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Change in VAS Score at monotherapy Cycle 4 (n=7)
|
0.571 units on a scale
Standard Deviation 13.377
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)Population: All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.
PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=52 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in NOD at Cycle 2 (n=52)
|
4.62 units on a scale
Standard Deviation 18.63
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in UOS at Cycle 2 (n=52)
|
-2.40 units on a scale
Standard Deviation 18.69
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
change in EIP at Cycle 2 (n=52)
|
2.88 units on a scale
Standard Deviation 21.38
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in NOD at Cycle 4 (n=34)
|
3.24 units on a scale
Standard Deviation 24.58
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in UOS at Cycle 4 (n=35)
|
-0.71 units on a scale
Standard Deviation 19.63
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in EIP at Cycle 4 (n=34)
|
-6.62 units on a scale
Standard Deviation 24.08
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in NOD at Cycle 6 (n=28)
|
9.29 units on a scale
Standard Deviation 24.78
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in UOS at Cycle 6 (n=28)
|
-1.79 units on a scale
Standard Deviation 16.57
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in EIP at Cycle 6 (n=28)
|
-1.79 units on a scale
Standard Deviation 28.81
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in NOD at monotherapy Cycle 2 (n=16)
|
11.88 units on a scale
Standard Deviation 32.29
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in UOS at monotherapy Cycle 2 (n=16)
|
-4.69 units on a scale
Standard Deviation 16.38
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in EIP at monotherapy Cycle 2 (n=17)
|
-4.41 units on a scale
Standard Deviation 35.61
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in NOD at monotherapy Cycle 4 (n=9)
|
8.89 units on a scale
Standard Deviation 18.33
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in UOS at monotherapy Cycle 4 (n=9)
|
2.78 units on a scale
Standard Deviation 23.20
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Change in EIP at monotherapy Cycle 4 (n=9)
|
2.78 units on a scale
Standard Deviation 23.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From enrollment to 30 days post-treatment discontinuation up to 26.4 monthsPopulation: All enrolled participants who received at least 1 dose of any study drug.
Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.
Outcome measures
| Measure |
Cetuximab + Pemetrexed + Carboplatin/Cisplatin
n=69 Participants
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|
|
Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)
Due to AE while on treatment
|
3 participants
|
|
Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)
Due to PD during 30-day FU
|
5 participants
|
Adverse Events
Cetuximab + Pemetrexed + Carboplatin
Serious events: 23 serious events
Other events: 63 other events
Deaths: 0 deaths
Cetuximab + Pemetrexed + Cisplatin
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab + Pemetrexed + Carboplatin
n=63 participants at risk
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
Cetuximab + Pemetrexed + Cisplatin
n=6 participants at risk
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.3%
4/63 • Number of events 4
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/63 • Number of events 3
|
0.00%
0/6
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chest pain
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Face oedema
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Immune system disorders
Anaphylactic reaction
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Bacteraemia
|
1.6%
1/63 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/63 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Lung abscess
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Pseudomonas infection
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Sepsis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Soft tissue infection
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
4.8%
3/63 • Number of events 3
|
0.00%
0/6
|
|
Infections and infestations
Urosepsis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Platelet count decreased
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Aphasia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Mental status changes
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.6%
1/63 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.6%
1/63 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.3%
4/63 • Number of events 5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
3.2%
2/63 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.6%
1/63 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
3/63 • Number of events 3
|
0.00%
0/6
|
|
Vascular disorders
Arterial rupture
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Haematoma
|
1.6%
1/63 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Cetuximab + Pemetrexed + Carboplatin
n=63 participants at risk
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
Cetuximab + Pemetrexed + Cisplatin
n=6 participants at risk
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.
Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.
Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.
Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
63.5%
40/63 • Number of events 60
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.7%
8/63 • Number of events 8
|
16.7%
1/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.9%
22/63 • Number of events 33
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
49.2%
31/63 • Number of events 58
|
50.0%
3/6 • Number of events 6
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Dry eye
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Growth of eyelashes
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
6/63 • Number of events 6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
9.5%
6/63 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
38.1%
24/63 • Number of events 29
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
17/63 • Number of events 22
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
7/63 • Number of events 7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/63 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
9.5%
6/63 • Number of events 7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.5%
6/63 • Number of events 6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
38.1%
24/63 • Number of events 33
|
83.3%
5/6 • Number of events 6
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
15.9%
10/63 • Number of events 12
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
15.9%
10/63 • Number of events 11
|
66.7%
4/6 • Number of events 6
|
|
General disorders
Asthenia
|
12.7%
8/63 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site erythema
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site inflammation
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site pain
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chills
|
7.9%
5/63 • Number of events 5
|
0.00%
0/6
|
|
General disorders
Face oedema
|
4.8%
3/63 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Facial pain
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
69.8%
44/63 • Number of events 47
|
83.3%
5/6 • Number of events 5
|
|
General disorders
Inflammatory pain
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
34.9%
22/63 • Number of events 30
|
50.0%
3/6 • Number of events 4
|
|
General disorders
Pain
|
12.7%
8/63 • Number of events 10
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
19.0%
12/63 • Number of events 13
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Thrombosis in device
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Candida infection
|
9.5%
6/63 • Number of events 8
|
0.00%
0/6
|
|
Infections and infestations
Folliculitis
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/63
|
16.7%
1/6 • Number of events 2
|
|
Infections and infestations
Paronychia
|
11.1%
7/63 • Number of events 7
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
6.3%
4/63 • Number of events 4
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
3/63 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
6.3%
4/63 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
6.3%
4/63 • Number of events 7
|
0.00%
0/6
|
|
Investigations
Platelet count decreased
|
7.9%
5/63 • Number of events 8
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
14.3%
9/63 • Number of events 9
|
50.0%
3/6 • Number of events 3
|
|
Investigations
White blood cell count decreased
|
15.9%
10/63 • Number of events 19
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.5%
23/63 • Number of events 25
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
20.6%
13/63 • Number of events 17
|
66.7%
4/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.9%
5/63 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.9%
5/63 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.6%
13/63 • Number of events 14
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
42.9%
27/63 • Number of events 37
|
33.3%
2/6 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.3%
4/63 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
4/63 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.3%
4/63 • Number of events 4
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
4/63 • Number of events 5
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.7%
8/63 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
7.9%
5/63 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.3%
4/63 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
11.1%
7/63 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
9.5%
6/63 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Depression
|
19.0%
12/63 • Number of events 12
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
9.5%
6/63 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
14/63 • Number of events 14
|
33.3%
2/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
10/63 • Number of events 10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.9%
10/63 • Number of events 11
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.7%
8/63 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.7%
8/63 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.6%
1/63 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
3/63 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.9%
5/63 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.9%
5/63 • Number of events 5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.9%
5/63 • Number of events 6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
21/63 • Number of events 32
|
66.7%
4/6 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
14/63 • Number of events 16
|
50.0%
3/6 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.9%
5/63 • Number of events 6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.8%
3/63 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
7/63 • Number of events 7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.3%
26/63 • Number of events 49
|
33.3%
2/6 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.3%
4/63 • Number of events 5
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.6%
1/63 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
Eyelid operation
|
0.00%
0/63
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
Gastrostomy
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Vascular disorders
Hypotension
|
12.7%
8/63 • Number of events 11
|
0.00%
0/6
|
|
Vascular disorders
Orthostatic hypotension
|
3.2%
2/63 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60